FDA-Device2021-12-29Class II
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Maquet Cardiovascular, LLC
Hazard
There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890.
Sold states
US Nationwide distribution in the states of IL and NC.
Affected count
2
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0403-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief